In 2010, approximately 8 million Americans 18 years and older were dependent on alcohol.

Vivitrol Pilot Study: SEMCA/Treatment Providers Collaborative Efforts with the treatment of Opioid Dependent Clients Hakeem Lumumba, PhD, CAADC SEMCA Scott Schadel, MSW, LMSW, CAADC HEGIRA PROGRAMS, INC. Oakdale Recovery Center Renee Shaw, MA, LPC, CAADC Salvation Army Harbor Light Monroe Michigan Alcohol Dependence Affects Many Americans In 2010, approximately 8 million Americans 18 years and older were dependent on alcohol. 1

Opioid Dependent Opiate dependent in the United States has increased significantly over the past decade (2002 2011). Addiction Treatment No single treatment can be prescribed for all individuals. So therefore matching treatment settings, interventions, and services to the client(s) needs is imperative to their overall success. 2

Brain Anatomy & Treatment Cortex Region-helps with decision making, thought process, reasoning, and learning Limbic Region-causes basic drive or urges, activates reward systems, and causing pleasures. In essence, counseling is designed to target the cortex region and Medications are designed to target the limbic region. Counseling The preferred type of treatment for addiction is counseling. Comprehensive treatment plan is developed through counseling Different counseling methods-individual, group, or psycho-education 3

Counseling continue Addressing the psychological aspects of addiction is crucial because: a) of the motivation to change evaluation b) aids with the building of recovery skills c) augment incentives for abstinence d) replace drugs/alcohol with rewarding activities. Treating Opioid Dependence with full and partial Agonist Full Opioid agonists (e.g., heroin and oxycontin) attach to opioid receptors in brain. Partial Opioid agonists (i.e., Suboxone) attach to opioid receptive and partially activate them. 4

Treating Opioid Dependence with an Antagonist or Blocking Medication Opioid antagonist (Vivitrol) attach to opioid receptors but do not trigger them Vivitrol Vivitrol is designed for the treatment of the followings: A) alcohol dependent patients who are able to abstain from alcohol in an ambulatory setting. Patients should not be actively drinking at the onset of Vivitrol administration. B) Prevention of relapse to opioid dependence post opioid detoxification Ultimately, Vivitrol should be part of a comprehensive management program that includes psychosocial support. 5

Contraindications Vivitrol is contraindicated in patients for the following conditions: a) Those receiving opioid analgesics b) Those in acute opiate withdrawal c) Those who have failed the naltrexone challenge test or have a positive urine drug screen for opioids d) Those who have exhibit hypersensitivity to naltrexone. Attributes of Vivitrol Vivitrol is: a) Monthly extended-release intravenous formulation of naltrexone. b) Administered by a healthcare professional c) Affective compliment to psychosocial treatment d) A competitive opioid blocker 6

Vivitrol is not: a) A narcotic b) Euphoric c) Addictive Attributes of Vivitrol d) Associated with abuse How Does Vivitrol Work? Vivitrol is a competitive antagonist (blocks medications) that attach to opioid receptor but does not trigger the brain s pleasure response. Patients must be detoxed prior to receiving Vivitrol Patients will not experience withdrawal when Vivitrol treatment is discontinued. 7

Vivitrol and Alcohol Dependence A study reported that alcohol dependent patients that participated in counseling and took Vivitrol compared to those that only participated in counseling had significantly fewer heavy alcohol consumption. In addition, patients that abstain from alcohol prior to the initial dose of Vivitrol (with counseling) had: a) Significantly more sober days b) Experienced more success maintaining complete abstinence during treatment. Vivitrol and Opioid Dependence A study revealed that opioid-dependent patients that participated in counseling along with Vivitrol therapy displayed greater measured clinical improvements than patients who participated in counseling absence of Vivitrol. Opioid dependent patients participating in counseling plus Vivitrol had: a) Significantly more days of complete abstinence. b) Remained in treatment longer c) Reported less craving d) Were less likely to relapse to physical dependence. 8

Clinical Endpoint: Rapid and Sustain Reduction in Craving In a study, craving was assessed with a weekly self-report visual analog scale. Vivitrol patients experienced a mean decreased from baseline over 6 months of 10.1 versus a mean increase of 0.7 for patients in the placebo group. Vivitrol Value Program $0 co-pay up to $500/month for eligible clients. See Alkermes representative for eligibility criteria. 92% of patients utilizing the program have no out of pocket expense for Vivitrol. Further information can be obtained either by the onsite representative or by calling 1.800.848.4876. Vivitrol is covered 100% by Michigan Medicaid with no prior authorization. See Vivitrol booth for further details 9

Program Information Oakdale Recovery Center Detoxification and Residential Substance Use Disorder Treatment Program Co-Occuring Disorders 45 Beds Male and Female Adults Public and Private Funding Candidate Criteria Funded by SEMCA without insurance Axis I Diagnosis of Alcohol or Opioid Dependence Presence or history of severe cravings Minimum 2 previous treatment episodes, with one being Residential Treatment Not taking naltrexone, /Suboxone, methadone, Antabuse, Campral, benzodiazepines History of general medication non-compliance 10

Candidate Criteria Completion of detox/drug & alcohol free minimum 7 days prior to drug administration; negative opioid and benzodiazepine UDS and breathalyzer Negative pregnancy test and no plans for a pregnancy within 6 months of drug administration and is not breast feeding Normal renal and hepatic function studies OR normal renal studies and liver enzymes Candidate Criteria Absence of anticipated surgery within next 30 days, chronic pain being treated with opioids, bleeding disorder, obesity/body habitus precluding IM injection with 2 needle, needle phobia, sensitivity/reaction to any injection Commitment to attend weekly/biweekly treatment as appropriate Motivated to maintain abstinence/remain drug free/in the early Action Stage of Change 11

Recruiting Process Current Clients within ORC s Residential SUD Treatment Program who have been in treatment 10-14 Clinical Team identified potential candidates Medical Director reviewed and approved Program Manager met with potential candidate to review Vivitrol Pilot Program and sign Consent Medical Director performs Psychiatric Evaluation and orders necessary Labs Pharmaceutical HPI s Pharmacist ordered all Vivitrol doses through Besse Medical Pharmacist ordered 3 doses at a time and monitored overall supply to streamline process ORC Nurses trained by Pharmacist and Alkermes Representative on Vivitrol and ORC s Protocol before giving injections Participants given first injection 3 days prior to discharge from Residential Treatment and evaluated by Nursing daily for possible adverse effects 12

Therapy and Support Aftercare Treatment with ORC s Day Treatment, IOP, or Outpatient Programs required Peer Recovery Coaches communicated with participants at least weekly throughout involvement with Pilot Program Peer Recovery Coaches scheduled monthly injections, made confirmation phone calls 24-48 hours prior to appointment, and provided transportation for Outpatient Therapy and injection appointments Participant Demographics 11 Participants 9 Males, 2 Females 10 Caucasian, 1 African American Age Range=26-49 All lived in Wayne County Drug of Choice=3 Alcohol, 7 Heroin, 1 other Opiates/Synthetics Average length of time using Drug of Choice=12 years 9 unemployed, 3 employed 13

Participant Demographics All have history of using other substances besides Drug of Choice 10 have Co-Occuring Mental Health Diagnosis Average length of time for use of all substances=12-30 years All Participants had not been prescribed Vivitrol in the past Post Pilot Results 2 Participants completed 6 month Pilot and 1 is still active Average number of days from 1st injection to dropout=48 7 out of 11 Participants did not have urges to use Drug of Choice 6 out of 11 Participants did not use any substance while enrolled in the Pilot 5 Participants employed during the Pilot (increase of 2) 14

Challenges Communication with Participants Staff Training Participation in Outpatient Treatment Participant Apathy SALVATION ARMY HARBOR LIGHT PARTICIPANT DATA 12 participants in the pilot 6 males and 6 females Previous treatment experience ranged from 2-9 admissions All were IV heroin users Years of heroin use ranged from 3-14 years 8 had positive changes in employment status 1 maintained employment status 15

Salvation Army Harbor Light Vivitrol Participant Experiences Vivitrol Injections ranged from 1-7 injections 2 females had injection site reactions (1 injection each) 1 male had withdrawal symptoms (1 injection) None had continuing urges to use drugs Treatment outcomes: 5 successfully completed 2 still in treatment 4 discharged for rules violations 1 left ASA SALVATION ARMY HARBOR LIGHT VIVITROL FOLLOW UP 4 FOLLOW UP SURVEYS WERE COMPLETED: REASON FOR PARTICIPATION: Thought it would help, Gave me piece of mind, It was free And I Knew I needed help with cravings All 4 felt it made a difference and helped with recovery All 4 would take Vivitrol again and recommend it to other people None had relapsed 16

References Hakeem Lumumba, PhD SEMCA 25363 Eureka Road Taylor, Michigan 48180 Hakeem.lumumba@SEMCA.Org 734.229.3510 Scott Schadel, MSW Hegira Program Oakdale Recovery Center 48325 Michigan Avenue Canton, Michigan 48188 Sschadel@hegira.net 734.397.3088 References Renee Shaw, MA Salvation Army Harbor Light 3250 N. Monroe Street Monroe, Michigan 48162 Renee_Shaw@usc.salvationarmy.org 734.384.3402 Alkermes Website: Alkermes.com Vivitrol Website: Vivitrol.com Alkermes Address: 852 Winter Street Waltham, MA 02451 781.609.6000 17